A Phase I Study of Combination Chemotherapy with Gemcitabine and Oral S-1 for Advanced Pancreatic Cancer

Ueno, Hideki; Okusaka, Takuji; Ikeda, Masafumi; Ishiguro, Yoriko; Morizane, Chigusa; Matsubara, Junichi; Furuse, Junji; Ishii, Hiroshi; Nagase, Michitaka; Nakachi, Kohei

doi:10.1159/000089997

Cited by 48 publications

(27 citation statements)

References 35 publications

(31 reference statements)

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“…Ueno and colleagues reported a good anticancer activity of the combination of S-1 with gemcitabine in 18 chemotherapy-naïve patients in a phase I trial (36). A median OS of 10.1 months and a median PFS of 5.9 months were subsequently shown by a phase II study (Ueno H, et al, Gastrointestinal Cancers Symposium: 148, 2007).…”

Section: Gemcitabine and Capecitabinementioning

confidence: 99%

Metastatic pancreatic cancer: Is gemcitabine still the best standard treatment? (Review)

Marco¹

2010

Oncol Rep

118

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Abstract. Pancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. Surgery remains the only treatment offering an advantage in terms of overall survival (5-year survival range, 15-25%), but unfortunately only 10-20% of patients present resectable disease at the time of diagnosis. Hence chemotherapy, possibly combined with radiation therapy, remains the only treatment option aimed at palliation of symptoms and ensuring a better quality of life. Notwithstanding the efforts to find more effective therapies for the treatment of pancreatic cancer, significant results have not yet been achieved. Increasing interest has focused on integrated treatments, i.e. chemotherapy combined with targeted therapies, and a better selection of patients. This study examines the principal clinical trials that will help give clinicians an overview of the progress made in the systemic therapy for advanced pancreatic cancer patients in recent years.

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Section: Gemcitabine and Capecitabinementioning

confidence: 99%

Metastatic pancreatic cancer: Is gemcitabine still the best standard treatment? (Review)

Marco¹

2010

Oncol Rep

118

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“…The modified schedule for combination chemotherapy using gemcitabine and S-1 described here was both feasible and tolerable, with ORR and TTP values comparable to those of previous 3-week regimens [6,7,8]. The median OS was 20.4 months, even though 15 of the 16 patients had distant metastases.…”

Section: Discussionmentioning

confidence: 58%

“…Combination chemotherapy with S-1 and gemcitabine has also been reported to be well-tolerated and active against advanced pancreatic cancer [6,7,8]. …”

Section: Introductionmentioning

confidence: 99%

A Pilot Study for Combination Chemotherapy Using Gemcitabine and S-1 for Advanced Pancreatic Cancer

Nakai¹,

Isayama²,

Sasaki³

et al. 2009

Oncology

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Objectives: We performed a pilot study of a modified combination chemotherapy regimen with S-1 plus gemcitabine for patients with advanced pancreatic cancer. Methods: Gemcitabine was administered at a dose of 1,000 mg/m² in a 30-min intravenous injection on days 1 and 15. S-1 was administered orally at a dose of 40 mg/m² twice daily for 14 consecutive days followed by a 14-day rest. Each cycle was repeated every 28 days. Results: Sixteen patients were enrolled. No complete response was observed and partial response was observed in 5 patients (31.3%), stable disease in 10 patients (62.5%) and progressive disease in 1 patient (6.3%). The median time to progression was 10.0 months (95% CI 4.4–N.A.) and the median survival time was 20.4 months (95% CI 8.6–24.1 months). The major toxicities were grade 3 neutropenia (25.0%) and grade 3 anemia (6.3%). There were no grade 4 toxicities. Conclusions: Combination therapy with gemcitabine and S-1 using the modified 4-week schedule was well tolerated and efficacious for advanced pancreatic cancer.

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“…Another Phase I study of the use of gemcitabine -S-1 combination chemotherapy with a different schedule was reported by Ueno et al (9). These investigators administrated 1000 mg/m 2 gemcitabine on Days 1 and 8 and 80 mg/m 2 S-1 from Day 1 to 14 followed by a 1-week rest.…”

Section: Discussionmentioning

confidence: 99%

“…In addition, synergy between gemcitabine and 5-FU in tumor cell lines, including pancreatic cancer cells, has been reported. The combination of S-1 and gemcitabine has shown promising clinical activity in Phase I clinical studies in advanced pancreatic cancer patients (8,9).…”

Section: Introductionmentioning

confidence: 99%

S-1 and Gemcitabine as an Outpatient-based Regimen in Patients with Advanced or Metastatic Pancreatic Cancer

Kim¹,

Lee²,

Jang

et al. 2008

Japanese Journal of Clinical Oncology

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Objective: The standard beneficial chemotherapy proved for patients with pancreatic cancer is a regimen containing gemcitabine. Novel oral fluoropyrimidine, S-1, can be added to gemcitabine to improve the efficacy of chemotherapy and to provide better convenience for patients. We aimed to evaluate the efficacy and safety of S-1 plus gemcitabine combination chemotherapy as a first-line treatment in patients with locally advanced or metastatic pancreatic cancer. Methods: Patients with histologically confirmed, bidimensionally measurable advanced/ metastatic pancreatic cancer were eligible for the study. Chemotherapy consisted of S-1 (30 mg/m 2 p.o. bid from Day 1 to 14) and gemcitabine (1000 mg/m 2 on Days 8 and 15) every 3 weeks based on the results of a previously reported Phase I trial. Treatment was repeated until disease progression or unacceptable toxicity occurred. Results: From January 2005 to August 2007, 22 patients were enrolled. Median age was 62 years (range, 50 -73). Nineteen patients (86.3%) had metastases and of these, 11 patients (57.9%) had multiple liver metastases. The overall response rate was 27.3% (95% CI, 8.7 -45.9), with a partial response in six patients, stable disease in nine (40.9%) and progressive disease in seven (31.8%). With a median follow-up of 25.4 months, the median time to progression and overall survival were 4.6 (95% CI, 2 -7.2 months) and 8.5 months (95% CI, 6.8 -10.1 months), respectively, and 1-year survival rate was 27.3%. S-1 plus gemcitabine was well tolerated. Grade 3/4 hematological adverse events were neutropenia (9.1/9.1%) and anemia (4.5/0%). Non-hematological adverse events were mainly gastrointestinal events. Twenty patients (91%) received chemotherapy on an outpatient basis. Conclusions: Combination chemotherapy of S-1 plus gemcitabine appears to be active and well tolerated as first-line treatment in patients with advanced/metastatic pancreatic cancer.

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A Phase I Study of Combination Chemotherapy with Gemcitabine and Oral S-1 for Advanced Pancreatic Cancer

Cited by 48 publications

References 35 publications

Metastatic pancreatic cancer: Is gemcitabine still the best standard treatment? (Review)

Metastatic pancreatic cancer: Is gemcitabine still the best standard treatment? (Review)

A Pilot Study for Combination Chemotherapy Using Gemcitabine and S-1 for Advanced Pancreatic Cancer

S-1 and Gemcitabine as an Outpatient-based Regimen in Patients with Advanced or Metastatic Pancreatic Cancer

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